Skip to main content
  • On-demand Webinar

Recent Brazil Regulatory Updates

Learn more about recent Brazil regulatory updates and what has changed.

Business colleagues collaborating in front of a brick wall with post-it notes

Watch now: Recent Brazil regulatory updates

Our Emergo by UL subject matter expert outlines the latest insights into Brazil’s regulatory updates.

Webinar date 

Feb. 6, 2024


Luiz Levy, RAC, manager, Quality and Regulatory Affairs Brazil

There have been a large number of regulatory developments in Brazil. Two resolutions have been published in quick succession related to medical devices and IVDs, RDC 751/2022 and RDC 830/2023, respectively.

This webinar will focus on the following:

Icon of a person with a gear inside their head

Update on RDC 751/2022

Observations from implementation and the experience gained since March. What are the impending deadlines? Have you updated your registrations? Find out what should be done and by when and what guidance exists to help.

Icon of a document with a stamp next to it

New regulations recently published

A list of the recent regulations published in the medical device sector

Icon of a balanced scale

Upcoming legislation based on two recent consultations

MDSAP GMP certification validity and leveraging global regulatory authorizations

Icon of a building with an information "i" at the center

Update on UDI regulation

Is my device impacted? Is ANVISA planning to postpone implementation of the UDI legislation?

Icon of a calendar

Upcoming UDI deadline

What is the current status of the UDI requirements in Brazil?

Icon of a hand holding a medical symbol

Update on ANVISA

What ANVISA is proposing and its impact on the medical device registration process

About the presenter

Luiz Levy, RAC, manager, Quality and Regulatory Affairs Brazil 

Luiz Levy is located in São Paulo, Brazil, and has over ten years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment and disposables subject to INMETRO Certification. Levy’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 665/2022, ISO 13485:2016, Directive 93/42/EEC, EU Regulation 2017/745 (MDR), FDA 21 CFR 807, FDA QSR 21 CFR 820, MDSAP-Medical device single audit program; performing multiple local and foreign (U.S., Europe, Japan) audits to prepare companies for ANVISA inspections; assisting companies during ANVISA inspections; compiling medical device and IVD applications; clinical data review; and compiling and peer reviewing market access reports.

As manager of Quality and Regulatory Affairs, Levy has peer-reviewed more than 300 regulatory filings and reports, conducted multiple on-site audits on local and foreign manufacturers, performed internal audits, and performed or reviewed more than 400 classifications/technical files of healthcare products. He also contributed to the final draft of new ANVISA (RDC) regulations during a series of strategic meetings with the Agency. Levy is the designated health manager for Emergo’s Brazil Registration Holder services, and he additionally manages Emergo Brazil’s RDC 665/2022 quality system. Prior to Emergo, he held RA/QA positions at CPL Medicals, Goen3 and Medics. 

Attend an upcoming webinar

Ready to elevate your industry IQ with insights and news from experts? Register for one of our upcoming events.

View upcoming webinars

Request more information from our specialists

Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.

Please wait…